DeviceClearance

Product code EMN— Dental

1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS

Classification name
Scaler, Periodontic
Device class
Class 1
Regulation
21 CFR 872.4565
Advisory panel
Dental
Total cleared
5
First cleared
Most recent

Market context for product code EMN

FDA has cleared 5 devices under product code EMN between 1978 and 2007, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code EMN

Recent clearances under product code EMN

Data sourced from openFDA. This site is unofficial and independent of the FDA.